BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4210560 · Received October 13, 2014

    Report

    Report Number
    2032227-2014-37299
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 13, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP HAD AN INTERMITTENT BUTTON RESPONSE DUE TO FLATTENED BUTTON DOME SWITCHES. INSULIN PUMP HAD SCRATCHES ON LCD WINDOW, CRACKED CASE NEAR LCD WINDOW CORNER, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES TO RESERVOIR TUBE WINDOW AND STAINED END CAP STICKER.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR INSULIN UMP KEYPAD WAS UNRESPONSIVE AND ALARMING. CUSTOMER STATED THEY DO NOT RECALL ANY SIGNIFICANT EVENTS THAT LED TO THE ALARM OR IF THE DEVICE WAS DROPPED. ADVISED CUSTOMER TO DISCONTINUE USE OF DEVICE AND REVERT TO BACK UP PLAN. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 183 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647351 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR